Monthly Headache Research Articles

Impact of headache frequency and preventive medication failure on quality of life, functioning, and costs among individuals with migraine across several European countries: need for effective preventive treatment

BackgroundData are limited regarding the combined impact of headache frequency and failure of preventive medication (efficacy and/or tolerability) on the humanistic/economic burden of migraine.MethodsA retrospective, cross-sectional analysis of 2020 National Health and Wellness Survey (NHWS) data was conducted. An opt-in online survey identified adults in France, Germany, Italy, Spain, and United Kingdom with self-reported physician-diagnosed migraine. Participants with ≥ 4 monthly headache days (MHDs) were stratified by prior preventive medication use/failure (preventive naive; 0–1 failure; ≥ 2 failures). Quality-of-life and economic outcomes were compared among groups using generalized linear modeling.ResultsAmong individuals with ≥ 4 MHDs (n = 1106), the NHWS identified 298 (27%) with ≥ 2 failures, 308 (28%) with 0–1 failure, and 500 (45%) as preventive naive. Individuals with ≥ 2 failures versus preventive-naive individuals had significantly lower scores on the 12-Item Short Form Survey Physical Component Summary (42.2 vs 44.1; P < 0.005), numerically higher scores on the Mental Component Summary (39.5 vs 38.5; P = 0.145), significantly higher scores on the Migraine Disability Assessment (39.1 vs 34.0; P < 0.05), and significantly higher prevalence of depression symptoms (62% vs 47%; P < 0.001) and anxiety symptoms (42% vs 31%; P < 0.01). The ≥ 2 failures group versus the preventive-naive group also had significantly more functional impairment as assessed by mean numbers of migraine-specific missed work days (7.8 vs 4.3) and household activities days (14.3 vs 10.6) in the past 6 months (P < 0.001) as well as the prevalence of absenteeism (19% vs 13%), overall work impairment (53% vs 42%), and activity impairment (53% vs 47%) (all P < 0.05). Emergency department visits (0.7 vs 0.5; P = 0.001) and hospitalizations (0.5 vs 0.3; P < 0.001) in the past 6 months were significantly higher in the ≥ 2 failures group versus the preventive-naive group, while indirect costs (€13,720 vs €11,282) and the proportion of individuals with non-adherence during the past 7 days (73% vs 64%) were numerically higher.ConclusionsIncreased burden, quality-of-life impairment, and functional impairment exist among individuals with migraine experiencing ≥ 4 MHDs and more treatment failures. While cause and directionality cannot be determined, these results suggest the need for effective preventive migraine treatments.Graphical

A Novel Virtual-Based Comprehensive Clinical Approach to Headache Care.

One major innovation, a result of the coronavirus pandemic, has been the proliferation of telemedicine. Telehealth can help solve the access problems that plague headache medicine, allowing patients in areas with no headache expertise to consult and work with a headache specialist. This is a retrospective chart review of patients seen by Neura Health, a comprehensive app-based telehealth headache center. Patients are seen by a specialist and, in addition to any medical recommendations, are given care plans individualized to their condition and recommendations at the end of their clinical appointments. The primary outcome of this study is a decrease in monthly headache days after 90 days; secondary outcomes include disability as determined by MIDAS score, depression determined by PHQ-9, patients' utilization of emergency department or urgent care resources, as well as their global impression of improvement. The deidentified outcomes of consecutive patients of Neura Health were evaluated from March 2022-March 2023. Subjects were excluded if they did not complete all forms, or if they did not receive a clinical or coaching follow-up appointment within 90 days. A total of 186 consecutive patients at Neura Health were identified during the review period. The median decrease in monthly headache days was 55.0% after a 90 day period, headache severity was decreased by 16.7%, global impression of improvement increased by 60.9%, disability decreased by 38.7%, depression decreased by 12.5% and ER/urgent care visits were decreased by 66.1%. A comprehensive, telehealth-based virtual headache-care model significantly decreased migraine frequency, severity and disability, and is able to decrease ER or urgent care visits.

Real-world efficacy and tolerability of fremanezumab in adults with chronic migraine: a 3-month, single-center, prospective, observational study.

Following the promising pre-marketing placebo-controlled randomized clinical trials of fremanezumab, post-marketing studies are necessary to verify efficacy and tolerability in various real-world settings. The present study assessed real-world efficacy and safety of fremanezumab. A 3-month, single-center, prospective, observation study of adults with chronic migraine who were treated with monthly subcutaneous injections of 225 mg fremanezumab in Denmark. The primary outcome was defined as proportion of patients who achieved ≥30% reduction in monthly migraine days (MMDs) from baseline to weeks 9-12. Among secondary outcomes were ≥50 and ≥75% responder rates and the proportion of patients reporting adverse events. A total of 91 patients with chronic migraine were enrolled and received at least one dose of fremanezumab of whom 89 patients (98%) completed the 3-months treatment period. At baseline, the mean (SD) number of monthly headache days was 24.3 ± 5.8 and mean number of MMDs was 18.5 ± 7.4. The number of patients who achieved ≥30% reduction in MMDs from baseline to weeks 9-12 was 58 (65%), while 45 (51%) and 21 (24%) had ≥50 and 75% reduction in MMD, respectively. Twenty-one patients (23%) reported adverse event, in which the most common were constipation (4.4%), fatigue (4.4%) and dizziness (3.3%). No serious adverse events were reported. In adult chronic migraine patients with previous failure of conventional oral migraine preventives, fremanezumab was found to be effective and well-tolerated.

Galcanezumab in patients with episodic migraine: results from the open-label period of the phase 3 PERSIST study

BackgroundThe phase 3 randomized PERSIST study demonstrated the efficacy and tolerability of galcanezumab, a humanized anti-calcitonin gene-related peptide (CGRP) monoclonal antibody for prevention of episodic migraines. We present findings from the open-label extension (OLE) of PERSIST, which evaluated the long-term efficacy and safety of galcanezumab in patients from China, India, and Russia.MethodsPatients completing the 3-month double-blind period of PERSIST were eligible for the 3-month OLE. Patients previously randomized to galcanezumab (GMB/GMB group) continued to receive galcanezumab 120 mg at all three visits during the OLE whereas patients randomized to placebo received a 240 mg loading dose of galcanezumab and then two 120 mg doses (PBO/GMB group). The primary outcome was the mean change (from double-blind baseline) in the number of monthly migraine headache days (MHDs) to month 6. Other endpoints included percent reduction in monthly MHDs from double-blind baseline to month 6, functional outcomes, safety and tolerability.ResultsOverall, 99% of patients completing the double-blind period entered the OLE, and 96% completed through month 6. Patients in the GMB/GMB group achieved continued improvements in efficacy, with the reduction from baseline in the mean number of monthly MHDs, and slightly increasing from 4.01 days at the end of the double-blind period to 4.62 at the end of the OLE. Of patients who were ≥ 50% responders to galcanezumab at month 3, 66% maintained this response through to month 6. Patients in the PBO/GMB group experienced a rapid reduction in the number of monthly MHDs after initiation of galcanezumab, with a mean reduction from baseline of 4.56 days by month 6. The long-term benefits of galcanezumab were also supported by improvements in other efficacy and functional endpoints. All safety findings were consistent with the known long-term safety profile of galcanezumab; no patients experienced a treatment-related serious adverse event.ConclusionsGalcanezumab was efficacious and well-tolerated in patients with episodic migraine from China, India and Russia, for up to 6 months.Trial registrationClinicalTrisABSTRACT_pals.gov NCT03963232, registered May 24, 2019.

Effect of COVID-19 Vaccination on Managing Chronic Migraine with Botulinum Toxin: A Case Series

Introduction: Although post-vaccination headaches have been reported following COVID-19 (Coronavirus Disease 2019) immunization, the specific effect of such vaccination on chronic migraine (CM) management utilizing botulinum toxin remains unexplored. This case series highlights the experiences of five CM patients who, despite initially responding well to abobotulinum toxin type A (BTX-A) treatment, experienced increased headache frequency post-COVID-19 vaccination. These findings suggest the potential implications of COVID-19 vaccination on the efficacy of CM management strategies. Case Presentation: This case series highlights five female patients diagnosed with CM, aged 31 - 50 years, with varying past medical histories and concurrent medications, whose number of headache days increased following COVID-19 vaccination (with either Sinopharm or AstraZeneca). All patients were undergoing an ongoing clinical trial at Sina Hospital in Tehran, Iran, receiving BTX-A treatment according to a standard protocol. Routine neurological examinations and brain MRIs (magnetic resonance imaging) were performed, and they were asked to complete monthly headache diaries detailing the frequency and intensity of headaches and abortive medications used. Conclusions: Based on the observed outcomes, the authors hypothesize that COVID-19 vaccination within the initial month of botulinum toxin administration could attenuate its efficacy in managing CM. Patients should be made aware of this possibility. Consequently, it is recommended that physicians might consider rescheduling the administration of BTX-A for CM management based on their clinical judgment.

Treatment with GLP-1 receptor agonists is associated with significant weight loss and favorable headache outcomes in idiopathic intracranial hypertension

BackgroundIn idiopathic intracranial hypertension (IIH), sustained weight loss is the main pillar in modifying disease course, whereby glucagon-like peptide-1 receptor agonists (GLP-1-RAs) could present an attractive treatment option.MethodsIn this open-label, single-center, case–control pilot study, patients with IIH (pwIIH) and a body mass index (BMI) of ≥ 30 kg/m2 were offered to receive a GLP-1-RA (semaglutide, liraglutide) in addition to the usual care weight management (UCWM). Patients electing for UCWM only served as a control group matched for age-, sex- and BMI (1:2 ratio). The primary endpoint was the percentage weight loss at six months (M6) compared to baseline. Secondary endpoints included the rate of patients with a weight loss of ≥ 10%, monthly headache days (MHD), the rate of patients with a ≥ 30% and ≥ 50% reduction in MHD, visual outcome parameters, and adverse events (AEs).ResultsWe included 39 pwIIH (mean age 33.6 years [SD 8.0], 92.3% female, median BMI 36.3 kg/m2 [IQR 31.4–38.3]), with 13 patients being treated with GLP-1-RAs. At M6, mean weight loss was significantly higher in the GLP-1-RA group (–12.0% [3.3] vs. –2.8% [4.7]; p < 0.001). Accordingly, weight loss of ≥ 10% was more common in this group (69.2% vs. 4.0%; p < 0.001). Median reduction in MHD was significantly higher in the GLP-1-RA group (–4 [–10.5, 0.5] vs. 0 [–3, 1]; p = 0.02), and the 50% responder rate was 76.9% vs. 40.0% (p = 0.04). Visual outcome parameters did not change significantly from baseline to M6. Median reduction in acetazolamide dosage was significantly higher in the GLP-1-RA group (–16.5% [–50, 0] vs. 0% [–25, 50]; p = 0.04). AEs were mild or moderate and attributed to gastrointestinal symptoms in 9/13 patients. None of the AEs led to premature treatment discontinuation.ConclusionsThis open-label, single-center pilot study suggests that GLP-1-RAs are an effective and safe treatment option for achieving significant weight loss with a favorable effect on headache, leading to reduced acetazolamide dosage in pwIIH.Graphical

Effects of Fremanezumab on Psychiatric Comorbidities in Difficult-to-Treat Patients with Chronic Migraine: Post Hoc Analysis of a Prospective, Multicenter, Real-World Greek Registry.

this post hoc analysis aimed to evaluate the efficacy of fremanezumab in difficult-to-treat chronic migraine (CM) patients with and without psychiatric comorbidities (PCs), mainly anxiety and/or depression. We assessed data from CM patients with and without PCs who failed at least 3 preventives and eventually received at least 3 consecutive monthly doses of fremanezumab 225 mg. Outcomes included the crude response (≥50% reduction in monthly headache days (MHDs)) rates to fremanezumab from the baseline to the last clinical follow-up. The changes in MHDs; MHDs of moderate/greater severity; monthly days with intake of abortive medication; and the proportion of patients' changing status from with PCs to decreased/without PCs were also compared. Disability and quality of life (QOL) outcomes were also assessed. Of 107 patients enrolled, 65 (60.7%) had baseline PCs. The percentage of patients with (n = 38/65; 58.5%) and without (n = 28/42; 66.6%) PCs that achieved a ≥50% reduction in MHDs with fremanezumab was comparable (p = 0.41), whereas MHDs were significantly reduced (difference vs. baseline) in both patients with PCs (mean -8.9 (standard error: 6.8); p < 0.001) and without PCs (-9.8 (7.5); p < 0.001). Both groups experienced significant improvements in all other efficacy, disability, and QOL outcomes at comparable rates, including in MHD reduction. A significant proportion of fremanezumab-treated patients with baseline PCs de-escalated in corresponding severities or even reverted to no PCs (28/65; 43.1%) post-fremanezumab. fremanezumab appears to be effective as a preventive treatment in difficult-to-treat CM patients with and without PCs while also being beneficial in reducing the severity of comorbid anxiety and/or depression.

Improving to Four or Fewer Monthly Headache Days Per Month Provides a Clinically Meaningful Therapeutic Target for Patients with Chronic Migraine.

Treatment target goals for patients receiving preventive migraine treatment are complicated to assess and not achieved by most patients. A headache "number" could establish an understandable treatment target goal for patients with chronic migraine (CM). This study investigates the clinical impact of reduced headache frequency to ≤ 4 monthly headache days (MHDs) as a treatment-related migraine prevention target goal. All treatment arms were pooled for analysis from the PROMISE-2 trial evaluating eptinezumab for the preventive treatment of CM. Patients (N = 1072) received eptinezumab 100mg, 300mg, or placebo. Data for the 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), and acute medication use days were combined for all post-baseline assessments and analyzed by MHD frequency (≤ 4, 5-9, 10-15, > 15) in the 4weeks preceding assessment. Based on pooled data, the percentage of patient-months with ≤ 4 MHDs associated with "very much improved" PGIC was 40.9% (515/1258) versus 22.9% (324/1415), 10.4% (158/1517), and 3.2% (62/1936) of patient-months with 5-9, 10-15, and > 15 MHDs, respectively. Rates of patient-months with ≥ 10days of acute medication use were 1.9% (21/1111, ≤ 4 MHDs), 4.9% (63/1267, 5-9 MHDs), 49.5% (670/1351, 10-15 MHDs), and 74.1% (1232/1662, > 15 MHDs). Of patient-months with ≤ 4 MHDs, 37.1% (308/830) were associated with "little to none" HIT-6 impairment versus 19.9% (187/940), 10.1% (101/999), and 3.7% (49/1311) of patient-months with 5-9, 10-15, and > 15 MHDs, respectively. Participants improving to ≤ 4 MHDs reported less acute medication use and improved patient-reported outcomes, suggesting that 4 MHDs may be a useful patient-centric treatment target when treating CM. ClinicalTrials.gov (Identifier: NCT02974153) ( https://clinicaltrials.gov/ct2/show/NCT02974153 ).

A Scoping Review and Meta-Analysis of Anti-CGRP Monoclonal Antibodies: Predicting Response.

Calcitonin gene-related peptide-targeted monoclonal antibodies (CGRP mAbs) are increasingly being used as preventive treatments for migraine. Their effectiveness and safety were established through numerous randomized placebo-controlled trials and real-world studies, yet a significant proportion of patients do not respond to this treatment, and currently, there is a lack of accepted predictors of response to guide expectations, as data from studies so far are lacking and inconsistent. We searched Embase and MEDLINE databases for studies reporting on predictors of response to CGRP and/or CGRP-receptor (CGRP-R) mAbs, defined as a 30% or 50% reduction in monthly headache or migraine days at varying durations of follow-up. Quantitative synthesis was performed where applicable. We found 38 real-world studies that investigated the association between various predictors and response rates. Based on these studies, good response to triptans and unilateral pain with or without unilateral autonomic symptoms are predictors of a good response to CGRP(-R) mAbs. Conversely, obesity, interictal allodynia, the presence of daily headaches, a higher number of non-successful previous prophylactic medications, and psychiatric comorbidities including depression are predictive of a poor response to CGRP(-R) mAbs. Future studies should confirm these results and help to generate more tailored treatment strategies in patients with migraine.

Neck Pain Disability on Headache Impact and the Association between Sleep Disturbance and Neck Pain in Migraine.

Neck pain (NP) is a prevalent symptom among migraine patients, but its disability on headache impact and the contributing factors for comorbid NP are poorly understood. This study aimed to investigate NP disability on the impact of headaches among migraineurs and factors linked to comorbid NP, including sleep-related variables. This cross-sectional study was conducted at a university hospital headache center, for headache patients at their first visits. Included in the study were 295 patients with migraines (217 females; 39.0 ± 10.8 years; 101 chronic migraine). Information on NP, history of physician-diagnosed cervical spine or disc disorders, detailed parameters of headache, and sleep and mood variables were collected. Logistic analysis of the severe impact of headache and contributing factors for NP were performed. NP was present in 153 participants (51.9%) with migraine, with high NP disability observed in 28 patients, and 125 patients had low NP disability. In multivariable analysis, NP disability, medication days per month, severe disability of migraine, and excessive daytime sleepiness were significant predictors for severe impact of headache. Thirty-seven patients with physician-diagnosed cervical spine or disc disorders were excluded from the NP analysis. Higher monthly headache days, female gender, and a high likelihood of obstructive sleep apnea were positively correlated with the presence of NP among migraineurs in multivariable analysis. Overall, the study highlights the potential impact of sleep-related variables and monthly headache days on NP in these patients. The high disability of NP was also associated with severe impact of headache.

Chronic Migraine Epidemiology and Outcomes - International (CaMEO-I) Study: Methods and multi-country baseline findings for diagnosis rates and care.

The Chronic Migraine Epidemiology and Outcomes-International study provides insight into people with migraine in multiple countries. This cross-sectional, observational, web-based cohort study was conducted in Canada, France, Germany, Japan, United Kingdom, and United States. An initial Screening Module survey solicited general healthcare information from a representative sample and identified participants with migraine based on modified International Classification of Headache Disorders-3 criteria; those with migraine completed a detailed survey based on validated migraine-specific assessments. Among 90,613 people who correctly completed the screening surveys, 76,121 respondents did not meet the criteria for migraine, while 14,492 did. Among respondents with migraine, mean age ranged from 40 to 42 years. The median number of monthly headache days ranged from 2.33 to 3.33 across countries, while the proportion of respondents with moderate-to-severe disability (measured by Migraine Disability Assessment) ranged from 30% (Japan) to 52% (Germany). The proportion of respondents with ≥15 monthly headache days ranged from 5.4% (France) to 9.5% (Japan). Fewer than half of respondents with migraine in each country reported having received a migraine diagnosis. These results demonstrated high rates of migraine-related disability and underdiagnosis of migraine across six countries. This study will characterize country-level burden, treatment patterns, and geographical differences in care.

Cluster and network analysis of non-headache symptoms in migraine patients reveals distinct subgroups based on onset age and vestibular-cochlear symptom interconnection.

The present study endeavors to identify natural subgroups of migraine patients based on the patterns of non-headache symptoms, utilizing cluster analysis. Subsequently, network analysis was performed to estimate the structure of symptoms and explore the potential pathophysiology of these findings. A total of 475 patients who met the diagnostic criteria for migraine were surveyed face-to-face during the period of 2019 to 2022. The survey included collecting demographic and symptom data. Four different solutions were generated by the K-means for mixed large data (KAMILA) clustering algorithm, from which the final cluster solutions were selected based on a series of cluster metrics. Subsequently, we performed network analysis using Bayesian Gaussian graphical models (BGGM) to estimate the symptom structure across subgroups and conducted global and pairwise comparisons between structures. Cluster analysis identified two distinct patient groups, and the onset age of migraine proved to be an effective characteristic differentiating the two patient groups. Participants assigned to late-onset group showed a longer course of migraine, higher frequency of monthly headache attacks, and greater tendency toward medication overuse. In contrast, patients in early-onset group exhibited a higher frequency of nausea, vomiting, and phonophobia compared to their counterparts in the other group. The network analysis revealed a different symptom structure between the two groups globally, while the pairwise differences indicated an increasing connection between tinnitus and dizziness, and a decreasing connection between tinnitus and hearing loss in the early-onset group. Utilizing clustering and network analysis, we have identified two distinct non-headache symptom structures of migraine patients with early-onset age and late-onset age. Our findings suggest that the vestibular-cochlear symptoms may differ in the context of different onset ages of migraine patients, which may contribute to a better understanding of the pathology of vestibular-cochlear symptoms in migraine.

A Retrospective Real-Life Multicenter Study on Concurrent Oral Preventive Treatments in Patients with Chronic Migraine Treated with OnabotulinumtoxinA.

OnabotulinumtoxinA (BoNTA) is a relatively safe and effective treatment for chronic migraine. The local mode of action of BoNTA favors the combination of oral treatments with systemic action. However, little is known about the possible interactions with other preventive treatments. The objective of the study was to describe the use of oral preventive treatments in patients with chronic migraine treated with BoNTA in routine clinical care and discuss the tolerability and efficacy according to the presence or absence of concomitant oral treatments. In this multicenter, observational, retrospective, cohort study, we collected data from patients with chronic migraine receiving prophylactic treatment with BoNTA. Patients were eligible if aged ≥18 years, diagnosed with chronic migraine according to the International Classification of Headache Disorders, Third Edition criteria, and treated with BoNTA according to the PREEMPT paradigm. We documented the proportion of patients with at least one concomitant treatment prescribed specifically for migraine (CT+M) and their side effects during four BoNTA treatment cycles. Additionally, we collected monthly headache days and monthly acute medication days from the patients' headache diaries. Patients with CT+M were compared to those without concomitant treatment (CT-) using a nonparametric approach. Our cohort included 181 patients taking BoNTA, of whom 77 (42.5%) received a CT+M. The most frequently prescribed concomitant treatments were antidepressants and antihypertensive drugs. Side effects in the CT+M group occurred in 14 patients (18.2%). Only in three of them (3.9%), the side effects had a significant interference with the patient's functioning (all in topiramate 200-mg/day users). Both CT+M and CT- groups had a significant reduction in monthly headache days of respectively -6 (95% confidence interval -9, -3; p < 0.001; w = 0.200) during cycle 4 compared with baseline versus -9 (95% confidence interval -13, -6; p < 0.001; w = 0.469). However, the reduction in monthly headache days was significantly smaller in patients with CT+M after the fourth treatment cycle compared with patients with CT- (p = 0.004). Prescription of oralconcomitant preventive treatment is common in patients with chronic migraine receiving BoNTA. We did not identify any unexpected safety or tolerability issues in patients receiving BoNTA and a CT+M. However, patients with a CT+M experienced a smaller reduction in monthly headache days when compared with those with CT-, which might be associated with a higher resistance to treatment in that subgroup of patients.

Patterns of response to anti-CGRP monoclonal antibodies during first 6-months of treatment in resistant migraine patients: impact on outcome.

The response pattern to monoclonal antibodies against calcitonin gene-related peptide (anti-CGRP MAbs) shown in migraine prevention clinical trials is not always reproducible at an individual-level. To describe patterns of start and consistency of the response to anti-CGRP MAbs during first six months of treatment and the association to baseline clinical characteristics METHODS: This is a prospective clinical cohort observational study. We included migraine patients treated with erenumab or galcanezumab evaluated at baseline and after three and six months (M3-M6) of treatment. The response was categorized according to reduction in monthly headache days (MHD): Sustained-response (SustainedR, ≥50% at M3 and M6); Short-Response (ShortR, M3≥50% and M6<50%), Later-Response (LaterR, M3<50% and M6≥50%); Limited-Response (LimitedR, 25-50% at M3 and M6) and No-Response (NoR, <25% at M3 and M6). Response patterns were compared at baseline and with outcome variables at M3 and M6. We included 357 patients with a headache frequency of 21.0(16.0, 28.0) MHD and 84.0% (300/357) were chronic migraine. The distribution according to response pattern was: 37.0% (110/297) Sustained-Response, 16.8% (50/297) Later-Response, 10.4% (31/297) Short-Response, 22.6% (67/297) Limited-Response and 13.1% showed No-Response (39/297). Sustained-R and Later-R groups showed statistically significant anxiety and depression score reduction at M3 and M6 compared to other groups. Initial response to anti-CGRP MAbs is not consistent in all patients. Persistence of anxiety and depression might be associated with lower response rates at month 6.

Real-Life Experience with Erenumab Therapy in the Episodic and Chronic Migraine. (P12-12.004)

<h3>Objective:</h3> The study aims to confirm the efficacy and safety of erenumab in migraine patients. <h3>Background:</h3> Migraine prevention with erenumab is approved in Kuwait. It is a fully human monoclonal antibody inhibiting the calcitonin gene-related peptide receptor (CGRPr). <h3>Design/Methods:</h3> This is a prospective, real-life, cohort study. In our tertiary hospital in Kuwait, we selected patients with a ICHD-3 diagnosis of migraine who received erenumab monthly between May 2019 and April 2022. The study included migraine patients aged 18 to 65 years treated with erenumab in the Headache clinic. Primary endpoint of this analysis was the mean change in monthly headache days from the baseline until the end of observational period. Secondary endpoints were changes days with acute headache medication in the treatment period, severity of headache pain and change of quality of after treatment. <h3>Results:</h3> A total of 151 migraine patients were identified to the study, 123 (81.5%) were female, with a mean age of 20.23±11.74 years. Erenumab decreased mean headache days frequency from 15.05 ± 8.93 to 6.08± 6.05; p&lt;0.002; mean monthly days of analgesic use from 15.48 ±8.77 to 6.30± 6.83; P &lt; 0.001), and mean severity of headache pain from 8.75± 1.67 to 5.46 ±2.90. Constipation (6%) was the most frequent adverse events reported. <h3>Conclusions:</h3> At the end of study, we reported a statistically significant reduction in the mean number of monthly headache days, acute medication use per month, and improvement of quality of life. Results of this real-world setting are comparable to results of clinical trials. <b>Disclosure:</b> Dr. Alshawaf has nothing to disclose. Dr. Ahmed has nothing to disclose. Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, Bayer, Novartis, Merck, Roche, Sanofi. Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bayer, Biogen, Novartis, Merck, Roche, Sanofi. Dr. Al-Hashel has nothing to disclose.

The relationship between anxiety and depressive symptoms and migraine-related outcomes in children and adolescents: a prospective clinical cohort study (P7-12.008)

<h3>Objective:</h3> The objective of this study is to explore the relationship between anxiety and depressive symptoms and migraine outcomes over time in children and adolescents. <h3>Background:</h3> Youth with migraine have more anxiety and depressive symptoms than their peers, but it is unknown if these impact migraine outcomes. <h3>Design/Methods:</h3> In this prospective longitudinal clinical cohort study, children and adolescents with migraine completed headache questionnaires and validated measures of anxiety and depressive symptoms (PROMIS) at an initial consultation and at their first follow-up visit with a neurologist. Migraine outcomes were the change in monthly headache frequency, and the change in migraine-related disability (PedMIDAS). The relationships between longitudinal migraine outcomes and baseline anxiety and depressive symptoms were estimated using multiple linear regression models controlling for sex, age, headache frequency, and treatment type. A priori sample size calculations were completed and we estimated that a sample size of n=118 was required to determine if baseline mental health symptoms would be associated with migraine outcomes (effect size=0.35, β=80%, α=0.05, 6 covariates). <h3>Results:</h3> Data were collected from 120 consenting participants. Baseline anxiety and depressive symptom levels were not significantly associated with change in headache frequency, nor with change in disability in univariate nor in multiple linear regression models (p&gt;0.05). In post-hoc exploratory analyses (N=72 that had complete anxiety and depressive symptom data at both visits), there was a significant association between change in migraine-related disability and change in anxiety symptoms between visits in multivariable models (ß=1.10, 95% CI=0.045–2.16, p=0.04). <h3>Conclusions:</h3> We found no relationship between baseline anxiety and depressive symptom levels and longitudinal migraine outcomes; this contradicts popular clinical belief that mental health symptoms predict migraine outcomes in children and adolescents. However, as disability improved, so did anxiety symptoms; this finding requires replication. <b>Disclosure:</b> Mr. Rizvi has received research support from University of Calgary . The institution of Ms. Cho has received research support from Canadian Institutes of Health Research. Mr. Kuziek has nothing to disclose. Dr. Ronksley has nothing to disclose. Dr. Noel has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Society of Pediatric Psychology. Dr. Noel has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for PAIN. Dr. Noel has received research support from CPCoE. The institution of Dr. Orr has received research support from Alberta Children’s Hospital Research Institute. The institution of Dr. Orr has received research support from Canadian Institutes of Health Research. Dr. Orr has received publishing royalties from a publication relating to health care. Dr. Orr has a non-compensated relationship as a Associate Editor with Headache: The Journal of Head and Face Pain that is relevant to AAN interests or activities. Dr. Orr has a non-compensated relationship as a Editorial Board with Neurology that is relevant to AAN interests or activities.

Post Hoc Analysis of PROGRESS: Evaluating the Safety of Atogepant in Participants With Chronic Migraine and Cardiovascular Risk Factors (P10-12.012)

Post Hoc Analysis of PROGRESS: Evaluating the Safety of Atogepant in Participants With Chronic Migraine and Cardiovascular Risk Factors (P10-12.012)

Real-World Effectiveness of Eptinezumab after Treatment with Subcutaneous CGRP Monoclonal Antibodies in Patients with Migraine (P12-12.009)

<h3>Objective:</h3> To evaluate the effectiveness of eptinezumab in patients with migraine after 6 and 12 months. <h3>Background:</h3> Patients who switched from subcutaneous CGRP mAbs to intravenous CGRP mAb (i.e., eptinezumab) are refractory to most preventive medications. While several real-world studies reported positive outcomes within 6 months of eptinezumab use, the eptinezumab usage pattern and treatment response after 1-year remain unknown. <h3>Design/Methods:</h3> This single-center retrospective study examined the first 30 subjects who received eptinezumab at the Jefferson Headache Center. We collected demographics, reasons for the switch, and usage pattern/response to eptinezumab after 6 and 12 months. The generalized estimating equation (GEE) test adjusted for age, sex, and BMI was used for repeated measure analysis. Missing data were not included. <h3>Results:</h3> We reviewed 30 patients (25 female, age 52.3±12.6, BMI 28.3±6.1) who experienced headaches for 26.8±17.8 years and switched to eptinezumab. At the index date, all subjects received a 100mg regimen and reported a mean monthly headache (MHD) of 24.6±8.6 and average pain intensity (API) of 6.2±1.8. After 6 months, 23 subjects continued, and 14 (61%) received a 300mg regimen. They had an MHD of 24.5±9.4 (n=16) and API of 5.7±1.4 (n=14). After 12 months, 15 subjects continued, and 10 (71.4%) were on a 300mg regimen. These subjects had an MHD of 22.5±10.5 (n=12) and API of 5.5±1.3 (n=12). The main reasons for eptinezumab discontinuation were inadequate response (n=6/15; 40%), intolerance (n=3/15; 20%), and insurance (n=5/15, 33%). There were insignificant reductions at 6 and 12 months of MHD (−0.71, 95%CI −3.42 to 2.00, p=0.61; −1.36, 95%CI −4.52 to 1.81, p=0.40) and API (−0.46, 95%CI −1.17 to 0.24, p=0.20; −0.63, 95%CI −1.38 to 0.13, p=0.11). <h3>Conclusions:</h3> In our study, patients may sustain no apparent benefit upon switching to eptinezumab after 6 or 12 months, reflecting the refractory nature of this study population. More prospective studies are needed. <b>Disclosure:</b> Miss Casaletto has nothing to disclose. Dr. Yang has nothing to disclose. Mr. Waters has nothing to disclose. Mr. Curran has nothing to disclose. Mr. Lowe has nothing to disclose. An immediate family member of Dr. Yuan has received personal compensation for serving as an employee of Merck. Dr. Yuan has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Trillen Medical. The institution of Dr. Yuan has received research support from NIH. Dr. Yuan has received publishing royalties from a publication relating to health care. Dr. Yuan has received personal compensation in the range of $0-$499 for serving as a Grant reviewer with NIH.

Beyond migraine headache day reduction: Clinically meaningful improvement in disability (MIDAS score) in the absence of greater than 50% reductions in monthly migraine days with galcanezumab (P10-12.008)

Beyond migraine headache day reduction: Clinically meaningful improvement in disability (MIDAS score) in the absence of greater than 50% reductions in monthly migraine days with galcanezumab (P10-12.008)

Treatment with Galcanezumab in Patients with Episodic Migraine: Results from the Open-Label Phase of the PERSIST Study (P10-12.006)

<h3>Objective:</h3> To assess efficacy and safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, in adult patients with episodic migraine. <h3>Background:</h3> Migraine is a neurological disorder with high disease burden and unmet clinical need. <h3>Design/Methods:</h3> This was a phase 3, double-blind (DB), randomized, placebo-controlled, 3-month study with a 3-month open-label extension (OLE). Eligible patients with episodic migraine were randomized to monthly subcutaneous injections of placebo (N=259) or galcanezumab 120mg with a 240mg loading dose (N=261). Patients entering OLE received galcanezumab 120mg/month. Efficacy measures included number of monthly migraine headache days (MHDs), ≥50% reduction in monthly MHDs, and Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain score. Change from baseline in continuous and categorical measures was analyzed using mixed model repeated measures analysis and generalized linear mixed models, respectively. OLE results are reported by prior DB treatment assignment. <h3>Results:</h3> Of the patients who completed DB treatment, 484 (99.4%) entered OLE, with 96.3% completing Month 6. From a baseline of 8.23 monthly MHDs at the beginning of DB, patients at month 6 in the prior placebo and galcanezumab groups had a mean change of −4.56 and −4.62, respectively. At Month 6, the percentage of patients with ≥50% response was 67.2% and 70.9%, respectively. Of the 142 galcanezumab-treated patients with ≥50% response at Month 3, 66.2% maintained that response throughout OLE. At Month 6, patient functioning on the 100-point MSQ-RFR increased from baseline by 24.9 and 23.7 points, respectively. The common (&gt;2%) treatment-emergent adverse events were injection site reaction (3.3%), upper respiratory tract infection (2.7%), and injection site pruritus (2.5%) during the OLE. Three patients (0.6%) discontinued due to an adverse event. There were no clinically meaningful changes in any safety parameters. <h3>Conclusions:</h3> Galcanezumab was effective, safe, and well tolerated during the PERSIST open-label extension in patients with episodic migraine. <b>Disclosure:</b> Prof. Yu has nothing to disclose. Prof. Zhou has nothing to disclose. Dr. Zhuang has received personal compensation for serving as an employee of Eli Lilly. Miss Liu has nothing to disclose. Ms. Qian has received personal compensation for serving as an employee of Eli Lilly.